Blood filtering component, apparatus, and method

ABSTRACT

An apparatus including a hollow body, an inlet fluidly coupled to the hollow body, a piston slidably engaged within the hollow body, and a filter module arranged within the hollow body between the inlet and piston. The piston and hollow body cooperatively generate a negative pressure, relative to ambient, within the hollow body during distal piston translation from a first position to a second position, thereby drawing a fluid, such as blood, through the filter module into the hollow body. The piston and hollow body cooperatively generate a positive pressure, relative to ambient, within the hollow body during piston translation from the second position to the first position to egress the filtered fluid from the hollow body. The filter module may include a filter housing, a filter medium disposed within the housing, and a body valve configured to seal an open distal face of the filter housing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. §119(e) of U.S.Provisional Application No. 62/276,817, titled “Blood FilteringComponent, Apparatus, and Method and filed Jan. 8, 2016, which is hereinincorporated by reference in its entirety. This application is also acontinuation-in-part of U.S. application Ser. No. 13/445,837, titled“Fluid Filtering Device and Method and filed Apr. 12, 2012, which isherein incorporated by reference in its entirety.

TECHNICAL FIELD

This disclosure relates generally to the field of medical devices, andmore specifically, to components, devices, and methods for filteringblood or other fluids.

BACKGROUND

Autologous blood transfusion is a process that removes a patient's ownblood from the body to later be re-transfused into the patient's body,as needed, during medical procedures. In developing countries,autologous blood transfusion techniques are commonly used due to thesmall quantities and high cost of donated blood available. Theseautologous blood transfusions are often performed manually. Currently,manual autologous blood transfusions involve collecting blood from anopen wound or a collection surface, manually removing large blood clots,filtering the blood through gauze pads to remove smaller blood clots andbiological particulates, and introducing the filtered blood into astorage bag where the blood is mixed with an anticoagulant solution andstored until the blood is needed by the patient. This process is verylabor, material, and time intensive, often involving the coordination ofthree or more trained personnel. Furthermore, this process can sufferfrom sterility issues. Thus, there is a global need for improved bloodtransfusion devices and methods.

SUMMARY

The present disclosure provides new and useful components, devices,systems, and methods of filtering blood and other fluids. In particular,various embodiments provided herein provide components, devices,systems, and methods for performing manual autologous bloodtransfusions. Various embodiments provided herein overcome one or moreof the shortcomings of previous manual autologous blood transfusionapparatuses and techniques.

One aspect of the disclosure is directed to a removable filter modulefor a blood filtering apparatus. The filter module includes a filterhousing, which is formed of one or more side walls and has a partiallyor fully open proximal face and distal face. The filter module furtherincludes: a filter medium disposed within the filter housing, and a bodyvalve positioned on a distal end of the filter housing. The body valveis movable between an open and a closed configuration. In the closedconfiguration, the body valve seals the distal face of the filterhousing. The body valve may open when a negative pressure is createdwithin the blood filtering apparatus and may close when the pressurereturns to ambient or a positive pressure.

In some embodiments, the filter module may be sized and configured tofit securely within a blood filtering apparatus and to form aliquid-tight seal with an inner wall of the blood filtering apparatus.Such a filter module may also include a sealing surface protruding fromthe one or more side walls of the filter housing, the sealing surfaceconfigured to compress against the inner wall of the blood filteringapparatus. The filter housing and the sealing surface may be monolithic;alternatively, the filter housing, the sealing surface, and the bodyvalve may all be monolithic; alternatively, the filter housing, sealingsurface, and body valve may each be separately formed and attachedduring the manufacturing process.

In some embodiments, the filter medium may be pleated. The filterhousing may be cylindrical. The body valve may be formed of a flap. Thefilter housing may be transparent.

Another aspect of the disclosure is directed to a filter module. Thefilter module includes: a filter medium formed of a pleated mesh foldedin a circular pattern, an elastomeric housing disposed at leastpartially around the filter medium, and a mechanical body valveconfigured to mechanically seal the filter module.

In some embodiments, the pleated mesh may form triangle-shaped facets,and the filter medium may be positioned in a circle around an innercolumn. The pleated mesh may have a plurality of pores sized to preventpassage of blood clots and large biological particulates through thepores while permitting passage of blood cells through the pores. Themechanical body valve may open to allow fluid to flow through the filtermedium when subjected to a negative pressure and close with ambient orpositive pressure. The mechanical body valve may be formed of a flapthat closes when external pressure is applied on the filter module andopens when pressure within the filter module is increased.

A further aspect of the disclosure is directed to a blood filteringapparatus. The blood filtering apparatus includes a fluid uptake devicehaving a fluid passageway, and any embodiment of the filter moduledescribed above or elsewhere herein. In various embodiments, the filtermodule is positionable within the passageway of the fluid uptake device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a side view of one embodiment of a blood filteringapparatus.

FIG. 2 illustrates a side view of one embodiment of a blood filteringapparatus.

FIGS. 3A-3B illustrate a side view of one embodiment of a bloodfiltering apparatus moving between an empty state and a filled state,respectively.

FIG. 4 illustrates a side view of one embodiment of a blood filteringapparatus.

FIGS. 5A-5B illustrate a side view of one embodiment of a bloodfiltering apparatus moving through an intake stroke and a compressionstroke, respectively.

FIG. 6 illustrates a side view of one embodiment of a blood filteringapparatus.

FIG. 7 illustrates a side view of one embodiment of a blood filteringapparatus.

FIGS. 8A-8C illustrate perspective views of one embodiment of a filtermodule for use in various embodiments of the blood filtering apparatus.

FIGS. 9A-9B illustrate perspective views of one embodiment of a filterhousing, which forms a portion of the filter module of FIGS. 8A-8C.

FIGS. 10A-10B illustrate perspective views of one embodiment of a bodyvalve flap, which forms a portion of the filter module of FIGS. 8A-8C.

FIG. 11 illustrates a perspective view of one embodiment of an innercolumn, which forms a portion of the filter module of FIGS. 8A-8C.

FIG. 12 illustrates a perspective view of one embodiment of a filter,which forms a portion of the filter module of FIGS. 8A-8C.

FIG. 13 illustrates an exploded view of the filter module embodiment ofFIGS. 8A-8C.

FIG. 14A illustrates a perspective view of one embodiment of a filtermodule having a body valve in an open position.

FIG. 14B illustrates a perspective view of the filter module embodimentof FIG. 14A, with the body valve in a closed position.

FIG. 15 illustrates a side view of one embodiment of a blood filteringapparatus formed of a fluid uptake device and a filter module.

DETAILED DESCRIPTION

The provided figures and the following description of certainembodiments of the invention are not intended to limit the invention tothese embodiments, but rather, are provided to enable any person skilledin the art to make and use this invention.

Disclosed herein are components, devices, and methods for filteringfluids; in some embodiments provided herein, the components, devices,and methods are configured for filtering blood during autologous bloodtransfusions.

As shown in FIG. 1, in some embodiments, an apparatus 100 for filteringblood or other fluids includes a hollow body 200, an inlet 300 fluidlycoupled to the hollow body 200, a piston 400 slideably disposed withinthe hollow body 200, and a filter module 500 located between the inlet300 and the piston 400. In the illustrated embodiments, the inlet 300 isat the proximal end and the piston 400 is at the distal end of theapparatus 100.

The apparatus 100 preferably functions to filter, store, and/ortransport blood. For example, the apparatus 100 can be used in bloodtransfusions, wherein the apparatus is used to filter blood drawn from apatient or from a collection volume, such as a bowl or a floor. Theapparatus preferably removes blood clots from the blood and canadditionally filter foreign particulates from the blood. The apparatusis preferably passive and manually operated by a user, but canalternatively be active and driven by an electronic system.

As visible, for example, in FIG. 2, the apparatus 100 can additionallyinclude a body valve 220 that controls fluid flow between the inlet 300and the hollow body 200. As described in more detail below, in someembodiments, the body valve forms a portion of the filter module 500. Insuch embodiments, the body valve is identified as body valve 520.

Additionally or alternatively, the apparatus 100 may include an outlet240 that allows egress of filtered fluid from the hollow body 200without passing back through the contaminated filter.

Additionally or alternatively, the apparatus 100 may include a reservoir320 fluidly coupling the inlet 300 to the hollow body 200. In some suchembodiments, the reservoir 320 is positioned between the inlet 300 andthe filter module 500. In other embodiments, the filter module 500 ispositionable within the reservoir 320.

Additionally or alternatively, the apparatus 100 may include an inletcoupling mechanism 340 that removably couples the inlet 300 to thehollow body 200; in some embodiments, the inlet coupling mechanism 340couples both the inlet 300 and reservoir 320 to the hollow body 200.

As shown in FIGS. 3A and 3B, the apparatus 100 is preferably configuredto move interchangeably between an empty state (see FIG. 3A) and afilled state (see FIG. 3B) via movement of the piston 400 in adistal-moving intake stroke 30 and a proximal-moving compression stroke40. During the intake stroke 30, the piston head 420 (i.e., the proximalend of the piston 400), moves distally from a first position 10relatively near the inlet 300 to a second position 20 relatively farfrom the inlet 300. During the intake stroke 30, the piston 400 andhollow body 200 cooperatively generate a negative pressure within thehollow body 200 relative to ambient. In other words, the piston 400applies a suction force to the hollow body interior that draws fluidthrough the inlet 300 and filter module 500 and into the hollow body200. During the compression stroke 40, the piston head 420 moves fromthe second position 20 to the first position 10. During the compressionstroke 40, the piston 400 and hollow body 200 cooperatively generate apositive pressure within the hollow body 200 relative to ambient. Inother words, the piston 400 applies an expulsion force to the hollowbody interior that expels fluid from the hollow body 200. The hollowbody 200, piston head 420, and body valve 220/520 preferablycooperatively define a hollow body volume that expands as the piston 400moves through the intake stroke 30, and contracts as the piston 400moves through the compression stroke 40. The filtered fluid, morepreferably filtered blood, preferably occupies the hollow body volumefollowing an intake stroke 30.

The apparatus 100 is preferably configured to minimize clotting as theblood is drawn into the hollow body 200. The apparatus preferablyminimizes clotting, at least in part, by controlling the blood flow rateinto and out of the apparatus. The apparatus 100 of some embodimentsallows for a blood flow rate between 0.5 L/min to 1.6 L/min. However,the apparatus 100 of other embodiments facilitates a higher or lowerblood flow rate. In one embodiment, the apparatus controls the bloodflow rate by controlling the maximum negative pressure (e.g., bycontrolling the inlet 300 to hollow body 200 cross-sectional ratio). Inone embodiment, the apparatus is configured such that the maximumnegative pressure does not exceed 150 mm Hg (below ambientpressure/atmospheric pressure) during the intake stroke. In anotherembodiment, the blood flow rate is controlled by the inlet 300 shape. Inanother embodiment, the blood flow rate is controlled by controlling therate at which the piston 400 is moved through the hollow body 200 (e.g.,by controlling the friction force applied by the piston head 420 againstthe hollow body 200 walls). However, any other suitable means or methodof controlling the blood flow rate can be included.

The piston 400 of the apparatus functions to generate the pressurechanges within the hollow body 200. As shown in FIG. 3B, the piston 400of some embodiments includes a piston head 420, a shaft 440, and ahandle 460, wherein the handle 460 preferably transfers an applied forceto the piston head 420 through the shaft 440. The piston head 420preferably has a substantially similar cross-section to the hollow bodyinterior, such that the piston head 420 perimeter forms a slidable sealwith the hollow body interior. The piston head 420 of some embodimentsis made of a flexible material, such as rubber, but in otherembodiments, it may be made of any suitable material that forms asubstantially airtight seal against the hollow body interior. The shaft440 of some embodiments has a cross-like cross-section. In otherembodiments, the shaft 440 is a solid rod, hollow rod, or any othersuitable form. The handle 460 of some embodiments is a T-shaped handle460; in other embodiments, the handle 460 may be a knob, bridge, or anyother suitable handle 460.

In one embodiment of the apparatus 100, the shaft 440 and the handle 460are removably coupled to the piston head 420. This can enable thefiltered blood to be stored within the apparatus instead of needing tobe egressed into a blood bag for long-term storage. The pressure balancebetween the hollow body volume and the ambient environment preferablymaintains the piston head 420 position when the shaft 440 and handle 460are removed, but the apparatus 100 can additionally include a lockingmechanism that retains the piston head 420 position. In one embodimentof the apparatus 100, the piston head 420 and shaft 440 are threadedsuch that rotation of the shaft 440 about its longitudinal axis removesthe shaft 440 from the piston head 420. In such embodiments, the hollowbody 200 interior and the piston head 420 perimeter can additionallyinclude complimentary threading (e.g., substantially near the secondposition 20), wherein rotation of the shaft 440 about its longitudinalaxis rotates the piston head 420 within the hollow body 200 to lock inthe piston head 420 position. Further rotation, preferably in the samedirection, decouples the shaft 440 from the piston head 420. In anotherembodiment, the piston head 420 and shaft 440 include a pin lockingmechanism, wherein a portion of the shaft 440 can be depressed torelease the shaft 440 from the piston head 420. Any other suitablecoupling mechanism can alternatively be used to couple the piston head420 and shaft 440.

The hollow body 200 of the apparatus 100 functions to cooperativelygenerate the positive and/or negative pressure with the piston 400; italso functions to hold ingressed fluid. The hollow body 200 canadditionally function to retain the relative positions of otherapparatus components, such as the filter module 500. The hollow body 200preferably has a substantially constant cross-section along its length,but it can alternatively have a variable cross section. The hollow body200 preferably has a circular cross section, but it can alternativelyhave an ovular, rectangular, polygonal, or any other suitable crosssection. In one embodiment of the apparatus, the hollow body 200 is ahollow cylinder. The hollow body 200 is preferably substantially rigid,and is preferably made of biocompatible materials. The hollow body 200can additionally include a coating on the hollow body interior, whereinthe coating is preferably a biocompatible coating. In some embodiments,the coating is an anticoagulant coating.

The hollow body 200 can additionally include a piston retention element,which functions to prevent complete piston removal from the hollow body.The position of the piston retention element within the hollow body canadditionally function to define the second position 20. The pistonretention element is preferably located along the hollow body 200 lengthdistal to the first position 10. The piston retention element ispreferably operable between a retention mode, wherein the pistonretention element retains the piston head within the hollow body, and arelease mode wherein the piston retention element allows complete pistonhead retraction from the hollow body (e.g., to allow for disassembly andsterilization). In one variation, the apparatus 100 includes one or morethrough-holes and one or more corresponding pins as the piston retentionelement, wherein the pins extend through the through-holes to blockpiston head retraction past the pins. The pins can be removably coupledto the through-holes to allow apparatus disassembly. However, any othersuitable piston retention element configuration can be used.

Additionally or alternatively, the hollow body 200 may include a pistonarrest distal the inlet 300, wherein the piston arrest preferablydefines the maximum distance that the piston 400 can travel away fromthe inlet 300.

The hollow body 200 may additionally or alternatively include a filterretention area including a series of grooves in which the filter module500 sits. The filter retention area is preferably located on theproximal end of the hollow body 200 in, adjacent to, or near thereservoir 320, but it can alternatively be located in any suitableposition.

The inlet 300 of the apparatus 100 functions to facilitate blood ingressinto the hollow body 200. The inlet 300 can additionally filter outlarge blood clots. In various embodiments, the inlet 300 is operativelyconnected to a proximal end of the hollow body 200. Preferably, theinlet 300 is concentric with the hollow body 200, but it canalternatively be coupled to any suitable portion of the hollow body 200.The inlet 300 is preferably a nozzle defining a straight channel;however, the nozzle can alternatively define a tapering channel, a swirlchannel, or any other suitable channel. The nozzle preferably has a flattip, but can alternatively have an angled tip, a threaded tip, a barbedtip, or any other suitable tip. Alternatively, the inlet 300 can be anyother suitable fluid inlet. The inlet 300 can additionally be configuredto minimize clotting during blood ingress. In one example of theapparatus 100, the ratio between the cross-sectional areas of the inlet300 and the hollow body 200 is configured such that the maximum negativepressure within the hollow body 200 does not exceed 150 millimeters ofmercury during the intake stroke. The inlet 300 is preferably removablycoupled to the hollow body 200, for example, being removably coupled viaan inlet coupling mechanism 340. In other embodiments, the inlet 300 isformed as a singular piece with the hollow body 200. The inlet 300 canadditionally include features for component attachment, such as barbs orthreading. Components that can be attached to the inlet 300 include aneedle, an IV tube, a blood bag, or any other suitable component.

As shown, for example, in FIG. 4, the inlet 300 can additionally includean inlet valve 302 positioned in the channel of the inlet 300 or betweenthe inlet 300 and the filter module 500. The inlet valve 302 ispreferably in an open position when the hollow body volume is undernegative pressure and in a closed position when the hollow body volumeis under positive pressure and/or at ambient pressure (e.g., atmosphericpressure). The inlet valve 302 is preferably a passive, one-way valve,but can alternatively be an active valve, a multi-way valve, or anyother suitable valve. Example inlet valves 302 include a duckbill valve,a switch valve, a ball valve, or any other suitable valve.

As shown, for example, in FIG. 4, the apparatus can additionally includean outlet 240 that functions to egress blood from the hollow body 200.The outlet 240 preferably provides a second fluid path for fluid egressthat is different from the path of fluid ingress/fluid filtration. Theoutlet 240 preferably permits fluid egress from the hollow body 200during the compression stroke, when positive pressure is applied to thehollow body interior. The outlet 240 is preferably located along thelength of the hollow body 200. In some embodiments, the outlet 240 ispositioned between the filter module 500 and the piston head 420 in thefirst position 10; in other embodiments, the outlet 240 is positionedbetween the filter module 500 and the piston head 420 in the secondposition 20. Thus, the filtered fluid does not need to flow through thecontaminated fluid to egress from the hollow body 200. The outlet 240preferably includes an outlet barb or threading to which a blood bag,tubing, or any other suitable transfusion mechanism can be coupled. Theratio between the cross-sectional area of the outlet 240 and the hollowbody 200 is preferably configured to limit the maximum positive pressureto a suitable pressure, for example, 150 millimeters of mercury.

The outlet 240 can additionally include an outlet valve 242 between theoutlet 240 and the body 200. The outlet valve 242 is preferably apassive, one-way valve, but can alternatively be an active valve, amulti-way valve, or any other suitable valve. Example outlet valves 242include a duckbill valve, a switch valve, a ball valve, or any othersuitable valve. In one embodiment of the apparatus 100, as shown in FIG.5A, the outlet valve 242 is preferably in a closed position when thehollow body volume is under negative pressure and/or is at ambientpressure (e.g., atmospheric pressure), and as shown in FIG. 5B, is in anopen position when the hollow body volume is under positive pressure.

In another embodiment of the apparatus, the outlet valve 242 is in anopen position when the hollow body volume is under negative pressure, inan open position when the hollow body volume is under positive pressure,and in a closed position when the hollow body volume pressure issubstantially equal to the atmospheric pressure. In this embodiment, ablood bag containing an anticoagulant solution can be coupled to theoutlet 240 prior to the intake stroke. When the piston 400 is movedthrough the intake stroke, blood and anticoagulant are simultaneouslydrawn into the hollow body volume through the inlet 300 and outlet 240,respectively, wherein the blood mixes with the anticoagulant within thehollow body volume. Translation of the piston 400 through thecompression stroke then pushes the anticoagulant-blood mixture into thecoupled blood transfusion device (e.g., blood bag). In this embodiment,the outlet 240 can additionally include a microfilter that functions tofilter microorganisms and/or particulates from the anticoagulantsolution prior to ingress into the hollow body volume; the microfilteris preferably removed prior to solution egress from the hollow body 200.In some embodiments, coupling a blood transfusion device (e.g., a bloodbag) to the outlet 240 can switch the outlet 240 from maintaining aclosed position during the intake stroke to maintaining an open positionduring the intake stroke.

Additionally or alternatively, the apparatus 100 can include a volume ofanticoagulant solution, for example, within the hollow body 200, whereinblood can mix with the anticoagulant solution upon ingress into thehollow body volume. The anticoagulant solution can include one or moreantithrombotics, such as heparin or coumarin compounds, one or morethrombolytics, such as streptokinase or urokinase, and/or one or moreantithrombocytics. The anticoagulant volume within the hollow body 200is preferably less than the maximum hollow body volume achieved when thepiston head 420 is in the second position 20. In some embodiments, theanticoagulant volume is less than half the maximum hollow body volume.Alternatively, any suitable volume of anticoagulant solution can beincluded, wherein the anticoagulant volume is preferably determinedbased on the concentration of the anticoagulant solution.

As shown, for example, in FIGS. 5A-7, the apparatus can additionallyinclude a reservoir 320 that couples the inlet 300 to the hollow body200. The reservoir 320 is preferably substantially hollow, and defines areservoir volume. The reservoir configuration preferably minimizes bloodclot formation, and preferably promotes laminar flow and/or minimizesturbulent flow between the inlet 300 and the hollow body 200. Forexample, in various embodiments, the reservoir 320 provides a smoothtransition between the inlet 300 and the hollow body 200. The reservoir320 can additionally provide a region for liquid and clotted blood toenter the apparatus 100 with sufficient volume for the liquid blood toseparate from the solid clots and enter the filter. The reservoir 320then acts as a storage area for the clots that cannot pass through thefilter. The reservoir 320 of some embodiments, such as the embodiment ofFIG. 6, is unoccupied by other apparatus components. In suchembodiments, the filter module 500 is positioned distal to the reservoir320. The reservoir 320 of other embodiments, such as the embodiment ofFIG. 7, is partially or wholly occupied by the filter module 500 (e.g.,when the filter module 500 is conical).

In one embodiment of the apparatus 100, the reservoir 320 is conical,the inlet 300 is located at the tip of the conical reservoir 320, andthe hollow body 200 couples to the base of the conical reservoir 320.The reservoir 320 can be a parabolic cone, an elliptical cone, afrustum, a cylinder, or any other suitable shape, wherein the inlet 300is preferably located at the reservoir apex, concentric with thereservoir central axis, but can alternatively be located in any othersuitable position. The reservoir 320 and inlet 300 are preferablymanufactured as a singular piece, but can alternatively be manufacturedas separate pieces.

Returning, for example, to FIG. 2, the apparatus can additionallyinclude an inlet coupling mechanism 340 that removably couples the inlet300 to the hollow body 200. More preferably, the inlet couplingmechanism 340 removably couples the reservoir 320 and inlet 302 to thehollow body 200. The inlet coupling mechanism 340 preferably enables theapparatus to be movable between an open and closed configuration. In theopen configuration, the reservoir 320 is at least partially decoupledfrom the hollow body 200 such that the filter module 500 can beaccessed. In some embodiments, the filter module 500 can be removed fromthe apparatus when the apparatus 100 is in the open configuration. Inthe open configuration of the inlet coupling mechanism 340, the bodyvalve 220/520 preferably seals the hollow body volume to preventcontamination. In the closed configuration, the reservoir 320 perimeterpreferably forms a fluid impermeable seal with the hollow body 200perimeter. The reservoir-hollow body junction can additionally includean O-ring or gasket to facilitate a better fluid seal. By allowing theapparatus 100 to be opened, the inlet coupling mechanism 340 can allowfor apparatus disassembly, which can facilitate apparatus componentsterilization (e.g., autoclaving), filter replacement, and apparatusreuse.

In one embodiment of the apparatus, the inlet coupling mechanism 340includes at least two complimentary connecting mechanisms. Theconnecting mechanisms may be evenly distributed about the reservoir 320and hollow body 200 perimeters. In another embodiment of the apparatus,the inlet coupling mechanism 340 includes a hinge rotatably connectingthe hollow body 200 and reservoir 320 and a connecting mechanism,wherein the connecting mechanism and hinge cooperatively seal thereservoir 320 against the hollow body 200 when the connecting mechanismis engaged. The connecting mechanism can include one or more clips,screws, adhesives, latches, clips, bayonet locking components,spring-force mechanisms (e.g., a rubber band that is stretched betweenthe reservoir 320 and the hollow body 200 distal the reservoir 320),complementary threading, or any other suitable coupling mechanism.

The filter module 500 of the apparatus 100 functions to separate bloodclots from the blood volume, wherein blood is preferably drawn acrossthe filter module 500 before entering the hollow body volume during theintake stroke. In some embodiments, the filter module 500 is arrangedwithin the hollow body 200 and preferably extends across an entire crosssection of the hollow body 200. The filter module 500 can alternativelybe partially or wholly located within the reservoir 320. The filtermodule 500 can have any suitable shape. The filter module 500 of someembodiments is cylindrical (e.g., disc-shaped) with a diametersubstantially equivalent to the hollow body interior diameter. In otherembodiments, the filter is conical; in one embodiment, the conicalfilter substantially fills the volume of the reservoir 320. The filtermodule 500 is preferably assembled such that it is concentric with thehollow body 200, but it can be assembled in any suitable positionrelative to the hollow body 200. The filter module 500 of someembodiments is coupled to the hollow body 200 (e.g., within a filtermodule slot). The filter module 500 of other embodiments is coupled tothe reservoir 320 (e.g., within a filter module slot). In someembodiments in which the reservoir 320 is removably attached to thehollow body 200, removal of the reservoir 320 simultaneously removes thefilter module 500 as well. In other embodiments, removal of thereservoir 320 exposes the filter module 500 for easy removal from thehollow body 200.

The filter module 500 preferably includes at least one porous filter.The pore size of the filter is preferably large enough to allow bloodcells (e.g., erythrocytes) to pass through the filter, and is preferablysmall enough to filter out clots. The pore size is preferably no morethan 170 μm (diameter), and in some embodiments, the pore size isbetween 40 μm to 170 μm, but in other embodiments, the pore size canalternatively be larger or smaller. The pore size can be selected basedupon the application (e.g., dependent on the species from which theblood originated). The pore size of some embodiments is substantiallyuniform throughout the filter, but in other embodiments, it uniformly ornon-uniformly varies throughout the filter. The filter of someembodiments has 50% porosity, but in other embodiments, the filter canhave any suitable porosity between 0% and 100%. The filter is preferablymade of a biocompatible material, such as nylon or polyester, but it canalternatively and/or additionally be made of cloth, paper, ceramic,coated polymers, coated metals, or any other suitable material. Thefilter of some embodiments is a substantially uniform, singular piece.In other embodiments, the filter is made of multiple pleated filtersextending radially from a central axis. The filter is preferably a discor block, but can alternatively be a membrane. The filter module 500 caninclude any suitable number of filters with any suitable pore size,wherein the filters with larger pore sizes are preferably disposedproximal to the filters with smaller pore sizes. In apparatus variationswith multiple filters, the filters are preferably adjoined (e.g.,touching the adjacent filter), but can alternatively be separated fromthe adjacent filter by a given distance.

One embodiment of a filter module 500 is shown in FIGS. 8A-8C. Theillustrated filter module may form a portion of an autologous bloodtransfusion device. For example, the filter module 500 may form aportion of any embodiment of the apparatus 100 described elsewhereherein. In various embodiments, the filter module 500 includes both afilter and a body valve, and the filter module is configured to bothfilter fluid and control the flow of fluid through the filter. Suchembodiments of the filter module are formed of a filter mesh 540 (alsoreferred to as a filter medium), a filter housing 510, and a body valveflap 520. The embodiments may additionally include an inner column 530.Examples of some individual components of the filter module are shown inFIGS. 9A-12. In particular, FIGS. 9A-9B provide one embodiment of afilter housing 510, FIGS. 10A-10B provide one embodiment of a body valveflap 520, FIG. 11 provides one embodiment of an inner column 530, andFIG. 12 provides one embodiment of a filter mesh 540.

In the filter module embodiment of FIGS. 8A-8C, the filter mesh 540 isdisposed in the filter housing 510. The filter housing 510 is formed ofa side wall and has partially or fully open proximal and distal faces.In some embodiments, the filter housing 510 is formed of a cylindricalside wall. In some embodiments, the filter housing includes one or moreprotrusions or other structural features on the side wall(s), forexample, to facilitate a fluid-tight seal between the filter module andthe adjacent portions of the blood filtering apparatus. For example, asshown in FIGS. 9A-9B, in some embodiments, the filter housing 510includes a side wall 512, one or more an outwardly extending protrusions514 at a first end, and one or more inwardly extending protrusions 516at a second end. In some embodiments, the outwardly extending protrusion514 acts as a sealing surface, compressing against the inner perimeterof the component in which the filter module 500 is positioned (e.g., thehollow body 200 or the reservoir 320) so as to create a seal between thefilter module 500 and the inner perimeter of the surrounding component.Such a seal prevents fluid from bypassing the filter medium. In someembodiments, the inwardly extending protrusion 516 acts as a sealingsurface, creating a seal between the filter housing 510 and the bodyvalve flap 520. The sealing surface 516 and body valve flap 520 togethercreate a temporary seal across a face of the filter module 500 so as toprevent fluid from exiting the filter module in the wrong direction.

In various embodiments, a body valve flap 520 is positioned across thedistal or proximal face of the filter housing 510. In some embodiments,the body valve flap 520 and filter housing 510 include interlockingfeatures, such as the mating holes 518 and protrusions 522 shown inFIGS. 9A-10B. Additionally or alternatively, an adhesive may be used tosecure the body valve flap 520 to the filter housing 510.

In some embodiments, the body valve flap and/or one or more sealingsurfaces (e.g., outwardly extending protrusions 514 and inwardlyextending protrusions 516) are integrally/monolithically formed with theside wall(s) 512 of the filter housing 510. In some embodiments, thesealing surface(s) 514, 516 and/or body valve flap 520 are separatelyformed and attachable to the filter housing. In some embodiments, thebody valve flap 520 is mechanically or chemically bonded to a portion ofthe side wall 512 of the filter housing 510 or the sealing surface 516.

The sealing surfaces of some embodiments are made of a thermoplasticelastomer, such as, for example, GLS Versaflex CL2242. The sealingsurfaces of other embodiments are made from any number of commonelastomers known to those skilled in the art. Exemplary materialsinclude, but are not limited to, Buna-N, EPDM, Fluorosilicone, Neoprene,Polyurethane, Silicone, and Viton. As shown, for example, in FIGS.14A-14B, in some embodiments, the entire filter module 500, or theentire filter module 500 except for the filter mesh 540, is made of atransparent material to allow for visual inspection for blood clots.

The filter 540 of various embodiments of the filter module 500 is formedof a mesh configured to remove any biological particulates not suitablefor autologous transfusion. In the illustrated embodiments, there aretwo layers of filter mesh. The first layer has a coarse pore size, forexample, with pores in the range of 800 microns to 1 mm. The secondlayer has a finer pore size, for example, in the range of 100-170microns; such a size allows blood cells to pass through the filter meshwhile preventing the passage of larger components, such as blood clotsand bone particulates. In other embodiments, one layer of mesh isprovided, while in other embodiments, three or more layers of mesh areincluded within the filter module. In various embodiments having atleast two filters with different pore sizes, the fine filter preferablyhas a pore size of less than 170 μm, and more preferably between 40 μmand 170 μm. The coarse filter preferably has a pore size larger than thefine filter, and is preferably located closer to the inlet 300 than thefine filter is, thereby acting as a pre-filter. By removing larger clotsbefore they can engage with the smaller pores of the fine filter, thecoarse filter can increase the longevity of the original filter bypreventing the fine filter from becoming clogged with the larger clots.The coarse filter of some embodiments has a pore size no more than 170μm (e.g., 80 μm, 100 μm, 150 μm, etc.), but in other embodiments, thecoarse filter has a pore size that is larger (e.g., 200 μm, 600 μm, 0.1mm, etc.). The coarse filter of some embodiments is adjoined to the finefilter; it can alternatively be retained a distance away from the finefilter. In one embodiment, both the coarse filter and the fine filterare discs of substantially the same diameter. In another embodiment, thecoarse filter is conical while the fine filter is substantiallyfrustroconical, wherein the coarse filter base has a diametersubstantially equal to the diameter of the smaller base of the finefilter, and the combined filter module 500 fits within the interiorvolume of the reservoir 320.

In one embodiment, the filter module 500 is in the form of a filtercartridge, which can be removably coupled to the hollow body 200 or thereservoir 320. In some embodiments, the hollow body 200 includes afilter cartridge slot that the filter module 500 is configured to fitwithin. The filter module 500 can be placed in or removed from thefilter cartridge slot. The filter module 500 and filter cartridge slotpreferably form a seal therebetween, such that blood flows substantiallythrough the filter, and does not leak through the perimeter of thefilter module 500. The apparatus can additionally include an O-ringbetween the filter module 500 and filter cartridge slot to facilitate asufficient seal.

During assembly of some embodiments, the filter mesh 540 is placed orformed within the filter housing 510. In some embodiments, for example,in some embodiments having a cylindrical filter module 500, the filtermesh 540 is pleated in alternating folds and wrapped in a circle aroundan inner column 530. The pleats of some embodiments form triangle-shapedfacets. In some such embodiments, each pleat of the filter mesh 540extends the entire height or a substantial height of the cylindricalside wall 512 with the folds at or near the top and bottom (i.e.,proximal and distal faces) of the side wall 512. The side wall 512 ofthe filter housing 510 and the inner column 530 stabilize the filtermesh 540 in place and help it maintain its shape. The inner column 530may be monolithically formed with the filter housing 510, or the innercolumn 530 may be securely adhered or otherwise attached to the filterhousing 510. In other embodiments, the filter module 500 may be sizedand shaped to fit within a non-cylindrical, tubular portion of a bloodfiltering apparatus 100. In such embodiments, the filter housing 510 mayhave a different polygonal shape, such as, but not limited to,rectangular. In such embodiments, the pleated filter mesh 540 may have amatching or otherwise complementary shape. For example, in someembodiments, both the filter housing 510 and the pleated filter mesh 540are rectangular. In such embodiments, the inner column 530 may not bepresent. In various embodiments, the filter mesh 540 is oriented suchthat the open faces of each fold are directed towards the open faces(i.e., the distal and proximal faces) of the filter housing 510.

A bonding method may be used to secure the filter mesh 540 to the filterhousing 510. In some embodiments, Loctite 5240 UV cure adhesive is usedto attach the filter to the housing. In other embodiments, othersuitable biocompatible adhesives (e.g., UV cure, air dry, vulcanizing,two-part) are used alone or in combination. Additionally, in someembodiments, the filter housing 510 is overmolded to the filter 540,embedding a portion of the filter mesh 540 within the filter housing 510and/or the inner column 530 (if present).

The filter mesh 540 is made of a material that is compatible with bloodand likely to minimize damage to blood as the blood passes through thefilter mesh. In certain embodiments, the filter mesh 540 is pleated andpresented in a circular shape, allowing for greater flow through thefilter than a flat disc. This maximizes the volume flow and reduces thestress on the red blood cells to prevent cellular rupture. If thepressure on the cells rises above 150 mmHg of pressure, the likelihoodof damage increases significantly. Alternately, the filter mesh 540 maybe presented in other configurations such as flat, curved, or conicalshapes. The housing 510 of some embodiments is made of an elastomer toenable a tight seal between the blood filtering apparatus 100 and thefilter module 500. The inner column 530 of some embodiments is made ofthe same or different elastomer as the filter housing 510. In otherembodiments, the inner column 530 is not elastomeric. In someembodiments, both the filter housing 510 and the inner column 530 (ifpresent) are bonded to the filter mesh 540 to prevent fluid frombypassing the mesh 540.

In some embodiments, on one of the open faces of the filter housing 510(i.e., on the proximal or distal end), the body valve flap 520 coversthe entire face and is partly attached to the filter housing 510. In apreferred embodiment, the body valve flap 520 covers the distal face ofthe filter housing 510. As described above, the body valve flap 520 maybe mechanically and/or chemically bonded to a portion of the filterhousing 510. The flap 520, which is flexible, opens by bending along ajoint such that the unattached portion of the flap 520 moves outwardaway from the filter housing 510. An example of an open configuration isshown in FIG. 14A. Opening of the valve flap 520 allows blood to flowthrough the filter mesh 540 and pass through to another chamber of ablood filtering apparatus 100 (e.g., the hollow body 200). When closed,as shown, for example, in FIG. 14B, the flap 520 rests against thefilter housing 510 and extends across the entirety of the face of thefilter housing 510 so as to seal the face and prevent any backflowthrough the filter 540. In various embodiments, the body valve flap 520opens when a sufficient pressure is created within the filter module500, for example, as occurs when the piston 400 of the blood filteringapparatus 100 is pulled distally upward or outward away from the filtermodule 500. The body valve flap 520 closes when the pressure within thefilter module 500 falls below a pressure threshold, for example, whenthe piston 400 of the blood filtering apparatus 100 is pushedproximally, towards the filter module 500. The flap 520 of variousembodiments is a flexible material configured to minimize the pressurerequired to bend the flap open and enable forward flow through thefilter 540.

In alternative embodiments of the apparatus 100, as shown for example inFIGS. 2, 4, 5A and 5B, the body valve controlling fluid flow into thehollow body 200 is separate from the filter module 500. In suchembodiments, the body valve 220 preferably extends across thecross-section of the hollow body 200, such that the body valve 220 canform a substantially fluid-impermeable seal against the walls of thehollow body interior. The body valve 220 is preferably located withinthe hollow body 200, between the filter module 500 and the piston 400.The general body valve location is preferably maintained substantiallystatic relative to the filter module 500 by the hollow body 200. Forexample, the body valve 220 of some embodiments rests within a groovedefined on the interior wall of the hollow body 200. The body valve 220is preferably a passive, one-way valve, but it can alternatively be anactive valve (e.g., electrically driven), a two-way valve, or any othersuitable valve. Examples of body valves 220 include switch body valves,duckbill valves, ball valves, or any other suitable valve.

The body valve 220/520 of various embodiments is preferably in an openposition during the intake stroke, when negative pressure is applied tothe hollow body interior. The body valve 220/520 is preferably in aclosed position during the compression stroke, when positive pressure isapplied to the hollow body interior, or when the hollow body interiorpressure is substantially equal to the pressure of the ambientenvironment (e.g., when the piston 400 is at rest relative to the hollowbody 200). By maintaining a closed position during the compressionstroke, as shown in FIG. 5B, the body valve 220/520 can facilitatepositive pressure generation within the hollow body volume, thusfacilitating blood flow out of the hollow body 200 via the outlet 240.Alternatively, the body valve 220/520 can be in an open position duringthe compression stroke, when positive pressure is applied to the hollowbody interior, wherein the blood within the hollow body 200 is egressedthrough the inlet 300. In another embodiment of the apparatus 100, thebody valve 220/520 moves between the closed state to the open stateduring the intake stroke, and moves from the open state to the closedstate during the compression stroke. The body valve 220/520 canalternatively have any other suitable configuration.

In some embodiments, the components of the apparatus 100 are made ofmaterials that can withstand sterilization processes, such as heatsterilization, radiation sterilization, or chemical sterilization.Example sterilization processes include autoclaving, UV light exposure,or bleaching. Furthermore, the apparatus components are preferably madeof one or more biocompatible materials, more preferably bioinertmaterials. Example materials include Topas-Cyclic Olefin Copolymers(TCOC), Makrolon® (Bayer MaterialScience), polycarbonate, polyethyleneterephthalate (PET), polytetrafluoroethylene (PTFE), polyethylene,polymethylmethacrylate (PMA), biocompatible polymers, biocompatibleceramics, and biocompatible metals, such as titanium, stainless steel.However, the apparatus components can be made of any suitable material.The apparatus components can additionally include a coating. In onevariation of the apparatus, the coating can decrease blood clotting. Inanother variation of the apparatus, the coating is a biocompatiblecoating; this can be desirable if the apparatus component is made of abiologically incompatible material. The coating can include silicone, ananticoagulant coating (e.g., EDTA, citrate, oxlate, etc.), or any othersuitable coating. The apparatus components are preferably injectionmolded, but can alternatively be sintered, stamped, or manufacturedusing any other suitable method.

In an alternative embodiment, the filtering module 500 described abovemay be used with an alternate blood filtering apparatus, such as theblood filtering apparatus of FIG. 15. As illustrated in FIG. 15, theblood filtering apparatus may be formed of any fluid uptake device 600that has a fluid passageway 610 and an ability to create a negativeinternal pressure within the fluid passageway 610 so as to facilitatefluid uptake. For example, the uptake device 600 may be an eye dropper(i.e., a Pasteur pipette), with a deformable top. Alternatively, theuptake device 600 may be a straw, tube, or pipe. In such embodiments,negative internal pressure may be created by manually sucking on adistal end of the uptake device or by connecting the distal end to apump, a vacuum, a deformable bulb, or other suitable device. In thesealternative embodiments, the filtering module 500 may be sized to fitwithin the passageway 610 of the fluid uptake device 600.

In one embodiment of a method, the method includes providing a bloodfiltering apparatus. The blood filtering apparatus may have any or allof the features described elsewhere herein. As one non-limiting example,the apparatus includes a hollow body 200, a reservoir 320 with an inlet300 connected to a hollow body 200 end, a piston 400 slidably disposedwithin the hollow body 200, and a filter module 500 within the hollowbody 200 between the piston 400 and the inlet 300. The filter module 500includes a filter 540 and a body valve 520. The hollow body 200 furtherincludes outlet 240, and an outlet valve 242, and the reservoir 320further includes an inlet valve 302. The reservoir 320 and hollow body200 may be removably coupled by a bayonet locking mechanism or any othersuitable connecting mechanism. The piston 400 includes a piston head 420with substantially the same diameter as the inner diameter of the hollowbody 200, a shaft 440 coupled to the piston head 420, and a handle 460coupled to the shaft 440.

The method further includes moving the piston 400 through the intakestroke, wherein movement of the piston 400 through the intake strokeopens the inlet valve 302 and the body valve 520 and draws fluid (e.g.,blood) through the inlet and the filter 540 into the hollow body 200. Inflowing through the filter 540, the fluid is separated from undesiredparticulates in the fluid. For example, blood may enter into the hollowbody 200, while the filter 540 blocks blood clots and large biologicalparticulates from passing through to the hollow body. The body valve 520may close upon completion of the intake stroke so as to prevent backflowof fluid through the filter 540. The method may additionally includemoving the piston 400 through the compression stroke, wherein movementof the piston 400 through the compression stroke opens the outlet valve242 and egresses fluid through the outlet 240. In some embodiments, ablood bag or transfusion tube is coupled to the outlet valve 242 priorto blood egress to collect the filtered blood. The valves are preferablyall closed when the piston 400 is not translating.

In another embodiment, movement of the piston 400 through the intakestroke opens the inlet valve 302, body valve 520, and outlet valve 242,simultaneously drawing blood and fluid (e.g., anticoagulant solution)from the blood source (e.g., patient or collection volume) and coupledblood bag, respectively. Movement of the piston 400 through thecompression stroke closes the inlet valve 302 and body valve 220 andopens the outlet valve 242, allowing blood egress out of the outlet 240into the blood bag.

In another embodiment, movement of the piston 400 through the intakestroke opens the inlet valve 302 and the body valve 520, and draws bloodthrough the filter into the hollow body volume. The piston 400 positionis retained by the substantially equal force between the hollow bodyvolume and the ambient environment. All valves are preferably closedwhen the piston 400 position is maintained. The reservoir 320 isdecoupled from the hollow body 200 and the filter module 500 removed;the closed body valve 520 preferably maintains the hollow body volumesterility and pressure during this process. The reservoir 320 is thenre-coupled to the hollow body 200, and movement of the piston 400through the compression stroke opens the body valve 520 and egressesblood through the inlet 300. The original reservoir 320 can be used, anew filter module 500 can be installed, or a new reservoir 320 can beused for blood egress from the hollow body volume. This alternative canadditionally include decoupling the piston 400 shaft 440 and handle 460from the piston head 420 to retain the piston 400 position.

As used in the description and claims, the singular form “a”, “an” and“the” include both singular and plural references unless the contextclearly dictates otherwise. For example, the term “a filter” mayinclude, and is contemplated to include, a plurality of filters. Attimes, the claims and disclosure may include terms such as “aplurality,” “one or more,” or “at least one;” however, the absence ofsuch terms is not intended to mean, and should not be interpreted tomean, that a plurality is not conceived.

The term “about” or “approximately,” when used before a numericaldesignation or range (e.g., to define a length or pressure), indicatesapproximations which may vary by (+) or (−) 5%, 1% or 0.1%. Allnumerical ranges provided herein are inclusive of the stated start andend numbers. The term “substantially” indicates mostly (i.e., greaterthan 50%) or essentially all of a device, substance, or composition.

As used herein, the term “comprising” or “comprises” is intended to meanthat the devices, systems, and methods include the recited elements, andmay additionally include any other elements. “Consisting essentially of”shall mean that the devices, systems, and methods include the recitedelements and exclude other elements of essential significance to thecombination for the stated purpose. Thus, a system or method consistingessentially of the elements as defined herein would not exclude othermaterials, features, or steps that do not materially affect the basicand novel characteristic(s) of the claimed invention. “Consisting of”shall mean that the devices, systems, and methods include the recitedelements and exclude anything more than a trivial or inconsequentialelement or step. Embodiments defined by each of these transitional termsare within the scope of this disclosure.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. Other embodiments may be utilized andderived therefrom, such that structural and logical substitutions andchanges may be made without departing from the scope of this disclosure.Such embodiments of the inventive subject matter may be referred toherein individually or collectively by the term “invention” merely forconvenience and without intending to voluntarily limit the scope of thisapplication to any single invention or inventive concept, if more thanone is disclosed. Thus, although specific embodiments have beenillustrated and described herein, any arrangement calculated to achievethe same purpose may be substituted for the specific embodiments shown.This disclosure is intended to cover any and all adaptations orvariations of various embodiments. Combinations of the aboveembodiments, and other embodiments not specifically described herein,will be apparent to those of skill in the art upon reviewing the abovedescription.

1-16. (canceled)
 17. A blood filtering apparatus, comprising: a filter housing formed of one or more side walls, the filter housing having a partially or fully open proximal face and distal face; a filter medium disposed within the filter housing; and a body valve positioned on a distal end of the filter housing, wherein the body valve is partially attached to the filter housing via a joint, the body valve movable between an open and a closed configuration, wherein, in the closed configuration, the body valve seals the distal face of the filter housing, and wherein, in the open configuration, the body valve bends at the joint such that one or more unattached portions of the body valve move outward away from the filter housing
 18. The blood filtering apparatus of claim 17, wherein the filter housing is sized and configured to fit securely within a blood filtering apparatus and to form a liquid-tight seal with an inner wall of the blood filtering apparatus.
 19. The blood filtering apparatus of claim 18, further comprising a sealing surface protruding from the one or more side walls of the filter housing, wherein the sealing surface is configured to compress against the inner wall of the blood filtering apparatus.
 20. The blood filtering apparatus of claim 19, wherein the filter housing and the sealing surface are monolithic.
 21. The blood filtering apparatus of claim 19, wherein the filter housing, the sealing surface, and the body valve are monolithic.
 22. The blood filtering apparatus of claim 17, wherein the filter medium is pleated.
 23. The blood filtering apparatus of claim 17, wherein the filter housing is cylindrical.
 24. The blood filtering apparatus of claim 17, wherein the filter housing is transparent.
 25. The blood filtering apparatus of claim 17, further comprising an inlet positioned on a proximal end of the body valve and configured to receive blood.
 26. The blood filtering apparatus of claim 17, further comprising a hollow body positioned at a distal end of the body valve and configured to store filtered blood.
 27. The blood filtering apparatus of claim 26, wherein the hollow body comprises a filter retention area configured to retain the filter housing.
 28. A filter module, comprising: a filter medium formed of a mesh; an elastomeric housing disposed at least partially around the filter medium, wherein the elastomeric housing comprises an inner column configured to create a hollow inner surface between a sidewall of the elastomeric housing and the inner column; wherein the elastomeric housing further comprises a sealing surface configured to create a seal between the filter module and a fluid uptake device configured to receive the filter module; and a mechanical body valve configured to mechanically seal the filter, wherein the mechanical body valve comprises a body valve flap movable between an open and a closed configuration, wherein, in the closed configuration, the body valve flap seals a distal face of the elastomeric housing, and wherein, in the open configuration, the body valve flap bends such that one or more unattached portions of the body valve flap move outward away from the elastomeric housing.
 29. The filter module of claim 28, wherein the mesh is pleated and comprises triangle-shaped facets, and wherein the filter medium is positioned in a circle around the inner column.
 30. The filter module of claim 28, wherein the pleated mesh has a plurality of pores sized to prevent passage of blood clots and large biological particulates through the pores while permitting passage of blood cells through the pores.
 31. The filter module of claim 28, wherein the mechanical body valve opens to allow fluid to flow through the filter medium when subjected to a negative pressure and closes with ambient or positive pressure.
 32. The filter module of claim 28, wherein the mechanical body valve comprises a flap that closes when external pressure is applied on the filter module and opens when pressure within the filter module is increased.
 33. A blood filtering apparatus, comprising: a fluid uptake device comprising a fluid passageway; and the filter module of claim 28 disposed within the passageway of the fluid uptake device. 